Blood vessel sealing system

ABSTRACT

A method of and apparatus for sealing access openings into blood vessels using an expandable member in the blood vessel on a control member that extends out through the access opening and an applicator which inserts a preformed sealing material into the access opening over the control member to keep the control member and expandable member centered in the access opening and withdrawing the collapsed expandable member back through the sealing material after the access opening is sealed.

BACKGROUND OF THE INVENTION

[0001] This invention relates generally to the stopping of bleeding fromblood vessels through openings in the vessel wall and more particularlythrough surgically produced punctures for different medical procedures.

[0002] Certain medical procedures require the percutaneous puncturing ofa blood vessel to gain access to the interior of the vascular system ofthe patient for the procedure to be conducted. Procedures that commonlyrequire such an percutaneous punctures are balloon angioplastyprocedures, arteriography, venography, angiography and other diagnosticprocedures that use blood vessel catheterization. Typically thepercutaneous opening or puncture is made into a relatively large bloodvessel such as a femoral artery. One of the difficulties in theseprocedures, however, is reclosure of the opening in the blood vesselwall after the procedure. In the past, manual pressure and/or mechanicalclamping pressure have been used to physically hold the opening closeduntil a blood clot formed with sufficient strength to keep the openingblocked until healing takes place. More recently, several techniqueshave been used to insert a collagen plug in the tissue access passage tothe blood vessel that promotes the formation of a coagulum at the vesselwall opening.

[0003] One such prior art technique simply inserts the collagen pluginto the access passage in the tissue to the vessel wall puncture. Thedifficulty with this procedure is that there is no practical way topositively limit the protrusion of the collagen into the interior of theblood vessel. This sometimes results in the collagen being inserted orsubsequently expanding through the blood vessel wall opening into thevessel lumen and causing a blood clot to form in the interior of theblood vessel. This is undesirable because the clot and/or the protrudingcollagen can dislodge and move along the blood vessel to cause anembolus. Also, the clot formed at the interior end of the puncture sitecan serve to undesirably restrict the blood flow past the site (i.e.thrombosis).

[0004] Another technique is to insert a sealing plug through the openingin the blood vessel wall with a first orientation and then turned to anorientation such that it will not pass back out through the opening. Thesealing plug is manipulated by a lanyard which extends back out throughthe tissue access passage exteriorly of the patient's body to bemanually held. The collagen plug is then passed down over the lanyardwhile the sealing plug is manually held in the blood vessel wallopening. Enough seepage of blood around the sealing plug is present toform the clot at the blood vessel wall opening. The sealing plug is leftin position in the blood vessel wall and is made out of a material whichis absorbable by the body over a several weeks or months period. Theproblem with this technique is that the sealing plug may break loosebefore it is absorbed by the body and cause a blockage of the blood flowthrough the blood vessel. The sealing plug may be a nidus for a bloodclot to form and subsequently dislodge resulting in embolization.Another potential problem in leaving a device inside the vessel wall isthat the device, like any foreign body, may erode the wall of the vesselor promote extensive intravascular scaring both of which potentiallywill disrupt vessel architecture.

SUMMARY OF THE INVENTION

[0005] These and other problems and disadvantages associated with theprior art are overcome by the invention disclosed herein by providing atechnique for implanting a collagen plug in the tissue access passage tothe percutaneous puncture or opening in a blood vessel which insuresthat the end of the plug does not extrude through the blood vessel wallopening into the blood vessel lumen. A tamponading means located insidethe blood vessel lumen during installation of the collagen plug servesto positively prevent the collagen plug from being inadvertently pushedthrough the blood vessel wall opening as it is installed but which isremoved after installation of the collagen plug so that no protrusion orother dislodgable material is left in the interior of the blood vesselafter the procedure is completed. The tamponading means is selectivelyexpandable to an expanded size and shape such that it will not pass backout through the blood vessel wall opening and its position in the bloodvessel is controlled by a control member extending exteriorly of thepatient for easy manipulation. For removal, however, tamponading meansis selectively collapsible to a collapsed condition small enough to passback out through the installed collagen plug without interfering withthe coagulum forming capability of the collagen plug. The technique issimple to use and the location of the collagen plug is inherentlyaccurately positioned at the blood vessel wall opening independently ofvariances in the patient's skin and tissue thickness at the puncturesite and without premeasuring or adjustment of the applicator.

[0006] The method of the invention is directed to the sealing apercutaneous puncture through a blood vessel wall comprising the stepsof inserting a collapsed expandable tamponading member attached to acontrol member into the blood vessel lumen through the blood vessel wallpuncture so that the control member extends out of the patient throughthe access passage to the skin surface; expanding the tamponading memberto a size larger than the blood vessel wall puncture; pulling theexpanded tamponading member back against the blood vessel wall openingusing the control member to form a seal at the interior end of the bloodvessel wall puncture; inserting a collagen plug into the access passagearound the control member while the seal is maintained at the bloodvessel wall puncture until the leading end of the collagen plug islocated at the exterior end of the blood vessel wall puncture; thencollapsing the tamponading member to the collapsed condition; andretracting the collapsed tamponading member back through the collagenplug. The collagen plug has a preformed passage therethrough whichslidably receives the control member to allow placement of the collagenplug along the control member. The collagen serves to induce a coagulumthat seals the outside end of the puncture in the blood vessel wall.After the collapsed tamponading member is pulled back through thecollagen plug, the collagen plug self seals any opening through the plugleft by the passage of the expandable member. The collagen plug may behoused in a retractable barrel while the collagen plug is inserted intothe access passage and the barrel then retracted from around thecollagen plug while maintaining the collagen plug in a substantiallyfixed position in the access passage. The barrel may be retracted fullyor partially from around the collagen plug before the expandedtamponading member is collapsed and withdrawn. The method may alsoinclude visually indicating when the projecting end of the collagen plugis located at the exterior end of the blood vessel puncture. Thecollagen plug may also be backed up while the collapsed tamponadingmember is withdrawn through the plug to insure that the plug remains inplace the collagen plug may also be urged slightly toward the bloodvessel wall puncture to compensate for any loss in volume of thecollagen plug as it turns into a gelatinous mass.

[0007] The apparatus of the invention comprises a temporary sealingarrangement including an elongate flexible control portion small enoughto pass through the blood vessel wall puncture with an expandabletamponading portion on the projecting end of the control portioncollapsible to a condition smaller than the blood vessel wall punctureand expandable to a condition larger than the blood vessel wall punctureso that it will not easily pull back through the puncture. An applicatoris provided to install the collagen plug in the access passage throughthe skin and tissue of the patient down to the exterior end of the bloodvessel wall. The applicator cooperates with the control portion of thetemporary sealing arrangement to fixedly locate the applicator withrespect to the exterior end of the blood vessel wall and facilitate thepositioning of the collagen plug with respect to the exterior end of theblood vessel wall puncture. The applicator includes a plug carryingassembly with a prescribed length used to insert the collagen plug. Thecontrol portion of the sealing arrangement includes indicia spaced aprescribed locating distance from that side of the expanded tamponadingportion facing the puncture to provide a visual indication that theleading end of the collagen plug is located at the exterior end of theblood vessel wall puncture. The plug carrying assembly has aninstallation barrel defining a plug carrying chamber therein adapted toreceive the collagen plug for installation in the access passage and aretraction arrangement is provided for selectively retracting theinstallation barrel from around the collagen plug while maintaining theplug at a substantially fixed position relative to the exterior end ofthe blood vessel wall puncture. The applicator may have a tighteningmechanism for pulling the expanded tamponading portion of the temporarysealing arrangement tighter against the blood vessel wall puncture asthe installation barrel is withdrawn from around the collagen plug. Theapplicator may also have an urging mechanism for urging the exterior endof the collagen plug toward the blood vessel wall with a slight forcejust sufficient to offset volume loss as the collagen plug softens to agelatinous mass on contact with body fluids. This is especially truewhile the collapsed tamponading member is being withdrawn. The expandedtamponading portion of the sealing arrangement may be an inflatableballoon with an inflation lumen through the control portion for use inselectively inflating the balloon to the expanded condition.

[0008] These and other features and advantages of the invention willbecome more clearly understood upon consideration of the followingdetailed description and accompanying drawings wherein like charactersof reference designate corresponding parts-throughout the several viewsand in which:

BRIEF DESCRIPTION OF THE DRAWINGS

[0009]FIG. 1 is a perspective view of a first embodiment of theinvention;

[0010]FIG. 2 is an enlarged longitudinal cross-sectional view of theapplicator;

[0011]FIG. 3 is an enlarged longitudinal cross-sectional view of theexpandable tamponading member;

[0012]FIG. 4 is an enlarged longitudinal cross-sectional view of thecoupling arrangement on the end of the control member;

[0013]FIGS. 5-9 illustrate one embodiment of the method of theinvention;

[0014]FIG. 10 is an enlarged longitudinal cross-sectional view ofanother embodiment of the expandable tamponading member;

[0015]FIG. 11 is a perspective view of a second embodiment of theinvention;

[0016]FIG. 12 is an enlarged transverse cross-sectional view taken alongline 12-12 in FIG. 11;

[0017]FIG. 13 is an enlarged transverse cross-sectional view taken alongline 13-13 in FIG. 11;

[0018]FIG. 14 is an enlarged transverse cross-sectional view taken alongline 14-14 in FIG. 11;

[0019]FIG. 15 is an enlarged perspective view of the collagen plug usedin that embodiment of the applicator seen in FIGS. 11-14;

[0020]FIG. 16 is a perspective view of a third embodiment of theinvention; and,

[0021]FIG. 17 is a longitudinal cross-sectional view of the collagenplug of the third embodiment of the invention; and

[0022]FIG. 18 is a longitudinal cross-sectional view of anotherembodiment of the invention.

[0023] These figures and the following detailed description disclosespecific embodiments of the invention, however, it is to be understoodthat the inventive concept is not limited thereto since it may beembodied in other forms.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0024] The blood vessel sealing system 10 is used to stop the bleedingfrom a percutaneous puncture BVP made in the wall BVW of a blood vesselBV as an incident to a medical procedure. Typically, the blood vessel BVused is a femoral artery in the groin region with a relatively largevessel passage or lumen BVL to facilitate locating the blood vessel andpermits a sufficiently large puncture to be made through the wall BVWthereof to carry out the procedure. Medical procedures which aretypically performed through such an puncture are angioplasty and otherprocedures which pass a catheter or other type probe into and along theblood vessel lumen BVL. When such a procedure is performed, an initialpercutaneous puncture with an appropriate needle is made from thepatient's skin through the tissue and the blood vessel wall into theblood vessel lumen and a guide wire installed. The needle is thenremoved leaving the guide wire in place and a tapered introducer guidesheath GS is installed over the guide wire to enlarge that portion ofthe puncture through the skin and tissue into an access passage AP whilethe blood vessel wall puncture BVP remains at about the originalpuncture size. The guide sheath GS serves to keep the passage open andprevent further damage to the tissue and skin around the passage. Theguide sheath GS is removed after the procedure is completed. This sheathGS assists in the installation of the sealing system 10 as will becomemore apparent.

[0025] Referring to FIG. 1, it will be seen that the sealing system 10embodying the invention includes generally a temporary sealing assembly11, a collagen plug 12 and an applicator 14. The sealing assembly 11 isinserted into the blood vessel lumen BVL through the introducer guidesheath GS and then the sheath removed leaving the sealing assembly inplace. The sealing assembly 11 serves to temporarily seal the interiorend of the puncture BVP in the blood vessel wall BVW while the collagenplug 12 is placed in the access passage AP to the exterior end of thepuncture BVP. After the collagen plug 12 is installed, the temporarysealing assembly 11 is removed through the collagen plug to insure thatnothing protrudes into the blood vessel lumen BVL to cause problemslater. The applicator 14 serves to install the collagen plug 12 in theaccess passage AP around the temporary sealing assembly 11 so thecollagen plug 12 can cause a coagulum to form at the exterior end of theblood vessel wall puncture BVP and stop the bleeding through thepuncture.

[0026] The sealing assembly 11 includes an elongate flexible controlmember 20 on which is mounted an expandable tamponading member 21. Thecontrol member 20 is designed for the projecting end 22 thereof to passthrough the guide sheath GS in the access passage AP and then throughthe puncture BVP in the blood vessel wall BVW into the blood vessellumen BVL while the opposite end 24 thereof remains exteriorly of thepatient. The projecting end 22 extends through the tamponading member 21sufficiently for the control member 20 to still extend into the bloodvessel lumen BVL after the tamponading member is removed from thepatient so that the tamponading member 21 can be reinserted if necessaryin the event of a failure. The exterior end 24 of the member 20 isprovided with a coupling 25 for connection to an expanding mechanism 26for selectively expanding the tamponading member 21 from a collapsedcondition as seen by solid lines in FIG. 1 closely adhering to thecontrol member outside surface to an expanded condition as will becomemore apparent.

[0027] It will be appreciated that the tamponading member 21 may bemechanically, electrically, pneumatically or hydraulically expanded andcollapsed without departing from the scope of the invention. Theparticular expanded exterior configuration of the tamponading member 21can be selected depending on the particular circumstances of use. Theconfiguration may be elongated in one direction and/or may have aflattened side facing the blood vessel wall puncture BVP after thetamponading member 21 is located in the blood vessel lumen BVL. Thecriteria that is used to determine the particular size and configurationis the blood vessel condition at the puncture BVP and thecross-sectional size and shape of the blood vessel lumen BVL in thevicinity of the puncture BVP. The largest cross-sectional dimension ofthe expanded tamponading member 21 must be small enough for the member21 to be pulled back against the interior end of the puncture BVPwithout dragging or hanging up in the blood vessel lumen BVL. It hasbeen found that an expanded dimension in one direction for the member 21that is at least about 1.5 times larger than the puncture BVP issatisfactory to prevent the tamponading member 21 from being pulled backthrough the puncture BVP under typical conditions. That portion of thetamponading member 21 at the puncture BVP must be larger than the sizeof the puncture BVP to insure sealing when the tamponading member 21 ispulled back up against the interior end of the puncture BVP as willbecome more apparent. While different expanded sizes may be used,dimensions on the order of 0.150-0.200 inch (3.8-5.1 mm) should besuccessful under typical conditions where the puncture BVP is made witha 4 french puncture. Without limiting the scope of the invention, theparticular tamponading member 21 illustrated in FIG. 3 is a smallinflatable balloon which can be inflated to a size and configurationsufficiently larger than the blood vessel wall puncture BVP to preventthe expanded balloon member 21 from being pulled back through thepuncture BVP while at the same time not hanging up in the blood vessellumen BVL in its expanded condition. In the expanded condition, themember 21 has a puncture facing side that is substantially normal to thecenterline of the control member 20. The inflatable balloon member 21may be made out of any suitable material such as latex. The balloonmember 21 is inflated and deflated through the control member 20 as willbecome more apparent.

[0028] The control member 20 is a thin elongate member similar in sizeand flexibility to the guide wire used to originally install the sheathGS in the access passage AP. The control member 20 is sufficiently longto extend from within the blood vessel lumen BVL out through thepuncture BVP and the access passage AP exteriorly of the patient so thatit can be manually manipulated and is also long enough that the guidesheath GS can be removed while manually holding the expanded tamponadingmember 21 in place over the puncture BVP to maintain the seal. To permitthe balloon member 21 to be inflated, the control member 20 defines aninflation lumen 28 therein seen in FIGS. 3 and 4 that extends from andcommunicates with the interior of the balloon member 21 along the lengthof the member 20 and opens out through the coupling 25. Thus, theballoon tamponading member 21 can be inflated and deflated through thelumen 28 from a position external to the patient.

[0029] The balloon member 21 is inflated by any convenient fluidinflation device such as the syringe 26 illustrated. Typically, thesyringe 26 or other inflation device will be of the same type as thatalready used in balloon angioplasty and has an extension 31 sizedsimilarly to the control member equipped with a mating coupling 30 to beselectively connected to the coupling 25 on the end of the controlmember 20. The inflation fluid under pressure from the syringe 26 flowsalong the inflation lumen 28 in the control member 20 into the balloonmember 21 to inflate same.

[0030] In those instances where it is necessary to remove the inflationdevice 26 after the balloon member 21 is inflated to the expandedcondition to complete the insertion of the collagen plug into the accesspassage AP, the balloon member 21 can be maintained inflated byproviding a check valve 29 on the exterior end 24 of the control member20. The check valve 29 may be incorporated in the coupling 25 or be aseparate member as shown in the drawings at FIG. 4. To deflate theballoon member 21 after the procedure is complete, the physician caninsert a needle into the valve 29 to open it or if the valve is aseparate member, the valve 29 can simply be removed from the coupling25. The outside diameter of the member 20 including the coupling 25 andthe check valve 29 should be as small as possible in order to passfreely through the puncture BVP and to pass through the collagen plug 12without significantly disturbing it. While different diameters may beused, diameters of 0.030-0.050 inch (0.8-1.3 mm) are satisfactory.

[0031] The applicator 14 best seen in FIGS. 1 and 2 includes a housingassembly 35 which mounts an introducer assembly 36 to house the collagenplug 12 while it is inserted into the access passage AP. A retractionmechanism 38 withdraws the introducer assembly 36 from around thecollagen plug 12 after it is inserted in the patient. An interconnectassembly 39 interconnects the control member 20 and the applicator 14 topositively locate the tamponading member 21 with respect to theintroducer assembly 36 is being withdrawn from around the collagen plug.A locator mechanism 40 is provided on the housing assembly 35 to beadjusted for a secondary fixed point of reference as the introducerassembly 35 is being withdrawn from around the collagen plug by theretraction assembly 38.

[0032] The housing assembly 35 includes an elongate cylindrical body 45with a hand grip 46 on one end thereof. The body defines an introducerpassage 48 seen in FIG. 2 centrally therethrough that receives theintroducer assembly 36 therein. A side slot 49 is defined through thewall of the body 45 and extends lengthwise of the body in alignment withthe hand grip 46 for the manually engageable portion of the retractionmechanism to extend for manipulation.

[0033] The introducer assembly 36 includes a thin wall insertion barrel50 slidably mounted in the body 45 of the housing assembly 35. Thebarrel has a projecting end 51 thereon that is inserted into the accesspassage AP and an opposite rear end. The barrel 50 defines a collagenplug receiving passage therein and is provided with an inwardly directedflange 52 at the rear end thereof. The barrel 50 has a length sufficientfor the barrel to project from the body 45 far enough for the barrel toextend along the access passage AP to the wall of the blood vessel BV.The barrel 50 is slidably mounted over a locator plunger 55 carried bythe body 45 of the housing assembly 35 to maintain the collagen plug inplace as the installation barrel 50 is being retracted. The plunger 55has an enlarged head 56 on the projecting end thereof which fills thecross-sectional space in the plug receiving passage under the flange 52when the barrel is fully extended. The smaller diameter support shaft 58of the plunger 55 slidably extends through the opening in the flange 52and is attached to the rear end of the body 45. Thus, as the barrel 50is pulled back along the plunger 55, the head 56 of the plunger holdsthe collagen plug in a fixed position with respect to the housingassembly 35 as will become more apparent. The projecting face of thehead 56 is spaced from the projecting end of the barrel 50 a distancesubstantially equal to the length of the collagen plug 12 when thebarrel 50 is fully extended from the body 45 with the flange 52 on thebarrel 50 against the rear annular face of the head 56 to insure thatthe plug will be properly in position.

[0034] The retraction mechanism 38 is attached to the barrel 50 andprojects through the slot 49 through the body 45. The mechanism 38 maybe any convenient arrangement which can retract the barrel 50 into thebody 45. The mechanism 38 illustrated as an example includes a connectorring 60 attached to the rear side of the flange 52 on the barrel 50 toslide in the passage 48 with the barrel and a manually engagableactuator member 61 attached to the ring 60 and projecting out throughthe slot 49 to be manually engaged and pulled back toward the hand grip46 pulling the barrel 50 therewith. The actuator member 61 isresiliently connected to the ring 60 so that it is urged away from thering and is equipped with a ratchet pawl 62 that prevents the ring 60and thus the barrel 50 from moving toward the trailing end of the body45 until the actuator member 61 is pulled back toward the hand grip 46.This action pivots the actuator member 61 and the ratchet pawl 62 out ofengagement with the wall of the body 45 to release the barrel 50 forretraction.

[0035] The applicator 14 has a prescribed overall length 11 when thebarrel 50 is extended. This length cooperates with the control member 20to let the physician know when the projecting end 51 of the barrel 50 islocated at the blood vessel wall BVW. The control member 20 is markedwith appropriate indicia 65 that will be exposed at the trailing end ofthe applicator 14 when the projecting end of the barrel and thus thecollagen plug is located at the exterior end of the puncture BVP throughthe wall of the blood vessel. Any appropriate indicia may be used,however, for purposes of illustration, the indicia 65 is shown is asafety band 66 spaced so that, as long as the safety band 66 is visibleon the trailing end of the applicator 14, the leading end of thecollagen plug 12 is located in the vicinity of the exterior end of thepuncture BVP. To prevent overinsertion of the collagen plug 12 into thepuncture, a warning band 68 is positioned inboard of the band 66 sothat, if the band 68 is visible, the plug 12 is overinserted into thepuncture BVP.

[0036] The interconnect assembly 39 is mounted on the housing assembly35 and serves to grip the control member 20 on the sealing assembly 11to interrelate the position of the applicator with the control member.The interconnect assembly 39 has a one way gripping arrangement 70 withappropriate ratchet teeth that permit the arrangement 70 and tamponadingmember 21 to move toward each as the arrangement 70 slides along thecontrol member 20 but prevents motion in the opposite direction. Thus,once the applicator 14 is on the control member 20, it can only beslipped toward the tamponading member 21. This serves to hold thehousing assembly 35 substantially fixed with respect the control memberand thus the tamponading member 21 while the barrel 50 is beingretracted.

[0037] The interconnect assembly 39 also has a tightening arrangement 71which slightly tightens the tamponading member 21 against the inside endof the puncture BVP while the barrel 50 is being withdrawn from aroundthe collagen plug 12. The tightening arrangement 71 is connected to theretraction mechanism 38 and the gripping arrangement 70 so that thegripping arrangement 70 is moved with the barrel 50 when the barrelinitially moves. The arrangement 71, however, releases the retractionmechanism 38 after the gripping arrangement 70 has moved the controlmember 20 a prescribed short distance which insures that the punctureBVP remains closed but insufficient to pull any portion of thetamponading member 21 through the puncture BVP.

[0038] The tightening arrangement 70 includes an extension 75 on theconnector 60 that projects rearwardly along the passage 48 to the rearend of the body 45. The rearwardly projecting end of the extension 75has a detent engaging cavity 76 therein. The forwardly projectingportion of the gripping arrangement 70 is connected to a resilientextension 78 with a detent 79 thereon that fits into the cavity 76 ofthe extension 75. The natural resiliency of the extension 78 urges thedetent 79 inwardly out of the cavity 76 to disconnect the extension 78from the extension 75. The passage 80 through the end of the body 45keeps the detent 79 and cavity 76 forced together until the forwardlyprojecting end of the extension 78 moves into registration with arelease cavity 81 in the body 45 opening into the passage 80. Thisreleases the gripping arrangement 70 from the extension 75 on thetightening arrangement 70 and also holds the gripping arrangement 70 ina fixed position with respect to the body 45 while the extension 75continues to move with the retraction of the barrel 50.

[0039] The locator mechanism 40 includes a locator pad 85 defining acentral passage therethrough to the slidably fit over the barrel 50. Atubular member 86 is attached to the pad 85 and extends over the forwardend of the body 45. The member 86 is divided into rearwardly directedresilient strips 88 that are equipped with inwardly facing one waygrippers that cooperate with complementary grippers 89 on the outside ofthe body 45. The grippers are arranged to permit the locator mechanism40 to be moved out over the barrel 50 until the pad 85 is against theskin but prevents movement in the opposite direction. This provides asecondary method for locating the applicator 14 with respect to theblood vessel wall puncture BVP.

[0040] To compensate for any loss of volume in the collagen plug 12 asit becomes a gelatinous mass, a compensator assembly 90 is provided.While different mechanisms may be used, the assembly 90 shown forpurposes of illustration is mounted in the projecting end of theenlarged head 56 on the plunger 55 and is activated as an incident tothe retraction of the barrel 50 off of the collagen plug 12. Theassembly 90 includes a pusher plate 91 with a support tube 92 slidablyextending into an annular passage in the head 56 and opening onto theend thereof. The plate 91 is urged out of the head 56 by a spring 94captured between the end of the tube 92 and the bottom of the passage.The tube 92 has a limiting stop on it to limit the extension of theplate 91 away from the end of the head 56. The amount of possibleextension from the head 56 is selected to correspond to the plug volumelost as the plug softens. The strength of the spring 94 is limited sothat the plate 91 will not force the plug 12 through the puncture BVP.The plate 91 is held in the retracted position until the barrel 50releases the plug by the friction between the plug and the barrel 50.

[0041] Method of Use

[0042] The method of sealing a blood vessel using the first embodimentof the invention is illustrated in FIGS. 5-9. As seen in FIG. 5, thetemporary sealing assembly 11 is installed while the introducer guidesheath GS is still in position. The temporary sealing assembly 11 isinstalled by threading the projecting end 22 thereof down through theguide sheath GS and into the blood vessel lumen BVL. The control member20 is threaded through the guide sheet GS until the collapsedtamponading member 21 passes into the blood vessel lumen BVL as seen inFIG. 5. Thereafter, the tamponading member 21 is expanded to itsexpanded condition with the syringe 26 and the guide sheath GS isremoved. The physician physically pulls back on the control member 20 sothat the expanded tamponading member 21 is pulled back up against theinside end of the puncture BVP through the blood vessel wall. Thetamponading member 21 is illustrated in the sealing position in FIG. 6.

[0043] After the tamponading member 21 is pulled up against the insideend of the puncture BVP, the applicator 14 with the collagen plug 12therein is inserted over the exterior end 24 of the control member 20 sothat the applicator and collagen plug is slipped toward the patient'sskin. It will be appreciated that the physician holds the control member20 to maintain the pressure of the tamponading member 21 against theinside end of puncture BVP at all times. After the applicator andcollagen plug are inserted over the control member 20 as seen in FIG. 6,the physician carefully slides the applicator 14 along the controlmember 20 so that the insertion barrel 50 on the introducer assembly 36passes into the access passage AP through the skin and tissue. Thephysician continues to push the applicator 14 toward the patient whileholding the control member 20 to keep the tamponading member 21 in placeuntil the safety band 66 of the indicia 65 on the control member 20becomes visible at the trailing end of the applicator 14. At this time,the projecting end 51 of the barrel 50 is located in the vicinity of theoutside end of the puncture BVP through the blood vessel wall BVW asseen in FIG. 7.

[0044] Since the one way gripping arrangement 70 of the interconnectassembly 39 prevents the applicator 14 from being moved back up thecontrol member 20, the collagen plug carried in the end of the barrel 50is positively located with respect to the blood vessel wall punctureBVP. The physician then slides the locator mechanism 40 out along thebody 45 until the locator pad 85 lies at the skin surface SS. Thisserves to stabilize the applicator 14 and also to act as a secondaryreference to locate the applicator 14 with respect to the outside end ofthe blood vessel wall puncture BVP as is also shown in FIG. 7. Thebarrel 50 is now ready to be withdrawn from around the collagen plug 12since the housing assembly 35 is fixed relative to the control member20. The housing 35 remains stationary while the physician pulls theactuator member 61 back toward the hand grip 46. This serves to retractthe barrel 50 while leaving the housing assembly 35 in place so that thelocator plunger 55 holds the collagen plug 12 in place. Although thebarrel 50 does not have to be fully retracted before the procedure iscompleted, it typically is fully retracted as seen in FIG. 8 to leavethe plug 12 in position in the access passage AP. As soon as the bodyfluids contact the plug 12, it starts to soften and any seepage of bloodthrough the blood vessel puncture BVP serves to start the formation of acoagulum at the exterior end of the puncture BVP. Typically, theapplicator 14 is left in position while the tamponading member 21 iscollapsed back to its original position and the control member 20 pulledto pull the tamponading member 21 back through the collagen plug 12 intothe applicator 14. By having a projecting end 22 on the control member20 long enough to still reach into the blood vessel lumen BVL with thetamponading member 21 within the applicator 14, contact is not lost withthe blood vessel lumen if something causes the collagen plug 12 not toproperly seal. This will facilitate re-access to the blood vessel lumenBVL. After the physician checks to see if the seal has been affected,the projecting end of the control member 20 can be pulled out throughthe collagen plug 12 to complete the procedure and leave the collagenplug 12 in place forming the coagulum CAM as seen in FIG. 9.

[0045] Alternate Embodiment of Sealing Assembly

[0046]FIG. 10 shows an alternate embodiment of the sealing assemblywhich has been designated as 111. The sealing assembly 111, like thesealing assembly 11, has an elongate flexible control member 120 with anexpandable tamponading member 121 mounted on the control member 120. Inaddition to the inflation lumen 128 which is provided through thecontrol member 120, an injection lumen 132 is provided along the lengthof the control member 120 and exits the control member 120 adjacent thetrailing end of the tamponading member 121 that faces the blood vesselwall puncture BVP. The size of the discharge port 134 through which theinjection lumen exits is selected to have a longitudinal length L₁ asseen in FIG. 10. The length L₁ is selected to be less than the thicknessof the blood vessel wall BVW at the puncture BVP. An appropriateinjection port (not shown) to the injection lumen 132 is provided in theexterior end of the control member 120.

[0047] This allows the physician to inject a detectable fluid throughthe injection lumen 132 and out the port 134 as the expanded tamponadingmember 121 is pulled back toward the puncture BVP. The physician canmonitor the flow of the protectable fluid along the blood vessel lumenBVL with appropriate equipment such as fluoroscopy. The physiciancontinues to pull the tamponading member 121 toward the wall BVW untilthe flow of the detectable fluid along the lumen BVL is stopped. Thisensures that the tamponading member 121 does not hang up on occlusionsor plaque within the blood vessel lumen and not seat good against theblood against the blood vessel wall BVW.

[0048] Second Embodiment of Applicator.

[0049] The second embodiment of the applicator is designated 114 and isillustrated in FIGS. 11-15. The basic difference between the applicator114 and the applicator 14 is that the applicator 114 has an open sectionthrough which the control member on the temporary sealing assembly canbe installed without feeding the control member axially through thecollagen plug and applicator. The applicator 114 like the applicator 14,includes a housing assembly 135, and introducer assembly 136, aretraction mechanism 138, an interconnect assembly 139, and a locatormechanism 140. These assemblies and mechanisms operate similarly to thecorresponding assemblies and mechanisms of the first embodiment of theinvention.

[0050] The cylindrical body 145 defines a V-shaped cutout 147 thereindown to the passage through which the control member on the temporarysealing assembly passes so that control member can be laid into thepassage as it is being operated to install the collagen plug. Theinsertion barrel 150 of the introducer assembly 136 is slit at 141 alongits length and the sidewall thereof is turned slightly inwardly so thatthe control member on the temporary sealing assembly can be pressedtherethrough. This slit 141 is also defined through the inwardlydirected flange 152. The locator plunger 155 is provided with a V-shapedcutout 142 that extends from the central passage through which thecontrol member passes to the exterior surface thereof. Similarly, thegripping arrangement 170 on the interconnect assembly 139 is providedwith a V-shaped cutout 143 to allow the control member to be placedlaterally into the passage up through the arrangement 170. It will beappreciated that the arrangement 170 still is able to grip the controlmember during use as with the first embodiment of the invention.Likewise, the locator pad 185 and tubular member 186 have a V-shapedcutout 144 to allow the control member to pass through the centerthereof. The body 145 is provided with a closure 195 that closes therear portion of the cutout through the body 145 to keep the controlmember in place once it is placed in the central passage running throughthe applicator.

[0051] The collagen plug 112 used with the second embodiment of theapplicator is illustrated in FIGS. 12 and 15 and includes a thinV-shaped cutout 196 which extends to the central passage through theplug 112 to receive the control member of the temporary sealingarrangement. While the plug 112 may work with a single V-shaped cutout196, it is illustrated with a wider opening section 198 adjacent theexterior surface thereof to facilitate placement of the control membertherein. It will be noted that the cutout comes together just before thecentral passage through the plug 112 is reached so that, once thecontrol member is snapped into the passage through the plug, it isretained therein.

[0052] Third Embodiment of the Invention

[0053]FIGS. 16 and 17 illustrate a third embodiment 210 of the inventionwhich includes a collagen plug 212 and an applicator tube 214. Thecollagen plug 212 is installed on the control member and the extension31 to the syringe 26 as described with the first embodiment of theinvention. The applicator tube 214 is a cylindrical tube defining acentral passage therethrough to just slidably receive the control memberof the temporary sealing arrangement. The physician simply slides thecollagen plug 212 and the tube 214 onto the control member of thetemporary sealing arrangement so that the leading end of the collagenplug 212 faces the access passage AP in the patient. The physician thenuses the applicator tube 214 to push the collagen plug 212 down to theoutside end of the puncture BVP. The combined overall length of thecollagen plug 212 and the applicator tube 214 corresponds to that of thefirst embodiment of the invention so that the physician can use theindicia 65 on the temporary sealing assembly to determine when theleading end of the collagen plug 212 is located in the vicinity of theoutside end of the puncture BVP.

[0054] The collagen plug 212 is made so that an outside layer 215thereon has a prescribed spring and softening rate so that the plug 212will not soften prior to being fully inserted into the access passageAP. The tapered leading end 216 on the collagen end 212 serves to keepthe collagen plug centered in the access passage AP and open it up toreceive the plug 212. The higher strength at the trailing end of thecollagen plug 212 permits the applicator tube 214 to push it into placebefore the plug softens.

[0055] Fourth Embodiment of the Applicator

[0056]FIG. 18 illustrates an alternate embodiment of the applicatorwhich has been designated by the reference of 314. The applicator 314include an insertion barrel 150 with the projecting end 351 thereonadapted to be inserted into the access passage AP in the patient. Thebarrel 350 defines an internal passage therethrough adapted to slidablyreceive the collagen plug 12 therein. A one-way check member 353 ismounted in the barrel 350 behind the plug 12 and has a face thereonabutting the plug 12 to maintain it lengthwise of the barrel 350 as willbecome more apparent. The check member 353 defines a tamponading memberreceiving chamber 352 which opens onto the trailing end of the plug 12and trailing end of the check member 353 is provided with a one-waygripping assembly 354 which grips the control member of the temporarysealing arrangement to allow the check member 353 to be moved along thecontrol member toward the expanded tamponading member but preventsmovement of the check member 353 in the opposite direction. A locatorplunger 355 extends into the barrel 350 behind the check member 353 tomaintain the check member 353 in position relative to the collagen plug12 as the collagen plug 12 is being installed. An appropriate driveflange 356 is provided on the trailing end of the plunger 355 projectingout of the barrel 350 to be manually engaged. The leading end of theplunger 355 is counterbored at 358 to receive the projecting portion ofthe check member 353 therein so that the leading end of the locatingplunger abuts the back side of the check member 353. The holding ring359 is provided on the trailing end of the barrel 350 so that thephysician can hold both the flange 356 and the ring 359 tosimultaneously push both the plunger 355 and the barrel 350 into theaccess passage AP. As soon as the leading end of the collagen plug 112is located in the vicinity of the outside end of the puncture BVP, thebarrel 350 can be withdrawn from around the collagen plug 12 simply bypulling out on the plunger 356 and the member 353. This is because thecheck member 353 prevents the collagen plug 12 from being withdrawn withthe barrel 350. After the collagen plug 12 is installed and thetemporary sealing assembly is ready to be withdrawn, the physician canhold the back side of the plug 12 while the collapsed tamponading member21 is pulled through the plug 12 into the recess 352. Because theprojecting end 22 on the control member 20 is smaller than the collapsedtamponading member 21, the rest of the control member can be pulled outof the plug 12 without damaging the plug.

What is claimed as invention is:
 1. A method of sealing an opening in ablood vessel wall through an access passage in the skin and tissue of apatient comprising the steps of: a) inserting an expandable memberattached to a control member into the blood vessel lumen through theopening in the blood vessel wall while the expandable member is in acollapsed condition smaller than the blood vessel wall opening so thatthe control member extends out of the blood vessel wall opening and theaccess passage exteriorly of the patient; b) expanding the expandablemember to an expanded condition larger than the blood vessel wallopening; c) pulling the expandable member back against the blood vesselwall opening using the control member to form a seal at the blood vesselwall opening; d) inserting a collagen plug into the access passagearound the control member while the seal is maintained at the bloodvessel wall opening until the collagen plug is located at the bloodvessel wall opening; e) after a coagulum is formed at the blood vesselwall opening to seal the opening, deflating the expandable member to thecollapsed condition; and, f) retracting the collapsed expandable memberthrough the collagen plug while leaving the collagen plug in position sothat the coagulum seals the opening through the collagen plug.
 2. Themethod of claim 1 wherein the step d) further includes the substep ofhousing the collagen plug in a tractable barrel member while thecollagen plug is inserted into the access passage; and, furtherincluding the step of: g) retracting the retractable barrel member fromaround the collagen plug while maintaining the collagen plug in positionin the access passage.
 3. The method of claim 1 further including thestep of inserting that portion of the control member extendingexteriorly the patient through the collagen plug between steps a) andb).
 4. The method of claim 1 wherein step further includes the substepof visually indicating when the end of the collagen plug is located atthe opening in the blood vessel wall.
 5. The method of claim 2 whereinstep g) further includes the substep of fixedly locating that end of thecollagen plug remote from the blood vessel wall opening with respect tothe blood vessel wall opening to maintain the collagen plug in positionwhile the retractable barrel member is removed.
 6. A blood vesselsealing system for sealing the wall opening in a blood vessel throughthe access passage formed through the skin and tissue in the patientcomprising: a) sealing means including an elongate control portionhaving a cross-sectional size smaller than the cross-sectional size ofthe access passage and the blood vessel wall opening, an expandableportion thereon having a collapsed condition smaller than thecross-sectional size of the access passage and the blood vessel wallopening and an expanded condition larger than the cross-sectional sizeof the access passage and the blood vessel wall opening, expanding meansor selectively expanding and collapsing said collapsible portion of saidsealing means; b) an elongate collagen plug defining opposed leading andtrailing ends thereon and a central passage therethrough adapted toreceive the control portion therethrough and to receive the expandableportion of said sealing means therethrough while aid expandable portionis in the collapsed condition; and, c) applicator means for selectivelyinserting said collagen plug into the access passage around said controlportion of said sealing means so that the leading end of said collagenplug is located at the blood vessel wall opening.
 7. The system of claim6 wherein said applicator means includes a plug carrying assembly havinga prescribed length for use in inserting said collagen plug into theaccess passage and, wherein said control portion of said sealing meansincludes an indicia marking thereon spaced a prescribed locatingdistance from said expandable portion to provide a visual indicationthat the leading end of said collagen plug is located at the bloodvessel wall opening.
 8. The system of claim 6 wherein said applicatormeans includes: an installation barrel assembly defining a plug carryingchamber therein adapted to receive said collagen plug therein forinstallation in the access passage; and retraction means for selectivelyretracting aid installation sheath from around said collagen plug whilemaintaining said plug at a substantially fixed position in the accesspassage.
 9. The system of claim 8 wherein said applicator meansincludes: tensioning means for increasing the pressure of saidexpandable portion of said sealing means in the expanded conditionagainst the blood vessel wall opening as said installation is withdrawnfrom around said collagen plug.
 10. The system of claim 6 wherein saidexpandable portion of sealing means is an inflatable balloon; whereinsaid control portion defines a fluid passage therethrough communicatingwith the interior of said balloon at one end thereof; and wherein saidexpanding means includes a controllable fluid source communicating withsaid fluid passage exteriorly of the patient for selectively supplyingfluid under pressure to said balloon to inflate and deflate same.